Family Dollar Antiseptic Mouth Rinse Blue Mint

Dosage form: mouthwash
Ingredients: Eucalyptol 0.092g in 100g, Menthol 0.042g in 100g, Methyl Salicylate 0.060g in 100g, Thymol 0.064g in 100g
Labeler: Family Dollar Services Inc.
NDC Code: 55319-130

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

DRUG FACTS:

Active ingredient:                                                   Purpose 

Eucalyptol 0.092%, Menthol 0.042%....................Antigingivitis, Antiplaque

Methyl Salicylate 0.060%, Thymol 0.064%...........Antigingivitis, Antiplaque

USE: 

Helps control plaque that leads to gingivitis.

Keep out of reach of children. If more than used for rinsing is accidentally swallowed, get

medical help or contact a Poison Control Center right away.

Warnings_____________________________________

Do not use if you have painful or swollen gums, pus from the gum line, loose teeth or increased

spacing between the teeth.  See your dentist immediately.  These may be signs of periodontitis,

a serious form of gum disease.

______________________________________________

Stop use and ask a dentist if gingivitis, bleeding or redness persists for more than 2 weeks.

children under 12 years of age - consult a dentist or doctor

____________________________________________________

- this rinse is not intended to replace brushing or flossing

Directions

adults and children 12 years - vigorously swish 20 mL (2/3 FL OZ or 4 teaspoonfuls)

of age and older                    between teeth for 30 seconds then spit out; do not swallow

__________________________________________________________________________

children under 12 years of age - consult a dentist or doctor

Other information cold weather may cloud this product.  Its antiseptic properties are not

affected.  Store at room temperature (59 - 77 F)

Inactive Ingredients

water, alcohol 21.6%, sorbitol solution, flavor, poloxamer 407,

benzoic acid, sodium saccharin, sodium benzoate, green 3

FAMILY DOLLAR ANTISEPTIC MOUTH RINSE BLUE MINT 
eucalyptol, menthol, methyl salicylate, thymol mouthwash
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55319-130
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Eucalyptol (Eucalyptol) Eucalyptol0.092 g  in 100 g
Menthol (Menthol) Menthol0.042 g  in 100 g
Methyl Salicylate (Methyl Salicylate) Methyl Salicylate0.060 g  in 100 g
Thymol (Thymol) Thymol0.064 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
Water 
Alcohol 
Sorbitol 
Poloxamer 407 
Benzoic Acid 
Saccharin Sodium 
Sodium Benzoate 
Product Characteristics
Colorgreen (FD&C green no. 3) Score    
ShapeSize
FlavorMINT (flavoring) Imprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:55319-130-011251 g in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35605/16/2011
Labeler - Family Dollar Services Inc. (024472631)
Registrant - Willard Manufacturing Inc. (208799143)
Establishment
NameAddressID/FEIOperations
Willard Manufacturing Inc.208799143manufacture

Revised: 05/2011
 
Family Dollar Services Inc.

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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